Embracing Cellular & Molecular Therapeutics

In 2009, in an attempt to improve patient outcomes, Austin Yeargan, MD, began to weave orthopedic biologics into surgical procedures for advanced rotator cuff tears with poor tissue using autologous mesenchymal stem cells. Impressive clinical results led to the treatment of irreparable cuff tears with an autologous mesenchymal cell impregnated acellular dermis graft and the treatment of chondral defects at the time of microfracture.

“I made that leap for people who had irreparable rotator cuff tears because it made sense biologically and clinically,” says Dr. Yeargan, who has kept pace with the scientific side of the techniques. Now with 13patients with over five years of follow up, Dr. Yeargan and his colleagues are finalizing data for a paper on that cohort.

Today, Dr. Yeargan’s practice, Regenerative Medicine Clinic of Wilmington (N.C.), offers biologic treatments for musculoskeletal disease and regenerative sports medicine in the appropriate setting. He typically performs one to four biologic procedures every week. Since it is still a pioneering practice, Dr. Yeargan treads lightly when selecting patients for his regenerative medicine procedures that can include treatment for pain in the setting of knee and shoulder osteoarthritis.

“We have found that the key is being extremely selective and I remain very conservative to avoid expectation/result mismatch,” Dr. Yeargan says. Part of the selection criteria includes identifying patients without advanced radiographic arthritic changes or alignment and instability issues. “Unfortunately, the majority of the patients who come to us for advice just aren’t good candidates for the techniques and are likely to be referred to colleagues for conventional and more predictable results for their pathology,” he says.

Dr. Yeargan agrees that some aspects of regenerative medicine are controversial and may be enjoying more widespread use than they should. “Understanding the biology behind what you are trying to accomplish clinically is critical. Unfortunately many types of physicians are diving headfirst into regenerative practices without that knowledge and little incentive to gain it.”

“Our clinical experiences with patient results using these techniques have enforced the notion that regenerative medicine deserves a place at the table and that there are many patients who could benefit,” says Dr. Yeargan. He is equally excited about the potential for gene therapy in orthopedics and thinks that holds at least as much promise. Contributions from scientists in the fields of cell and molecular biology, materials science, chemistry and math will continue to further advancement of that aspect of the field.

“What we have right now is not perfect, but it’s the best we have right now and patients are definitely experiencing excellent and predictable clinical results before our eyes,” says Dr. Yeargan, who expects the field to mature exponentially over the next ten years, primarily due to the work scientists are doing behind the clinical scenes. “Deciphering the complex genetic programming and molecular signaling pathways involved is a sizable task but is progressing daily,” Dr. Yeargan says. Like learning any foreign language, these processes are likely to take years of focus and dedication to understand.

 

“Advancing the field probably requires regulatory models, because too many people are offering myriad regenerative medicine procedures for everything under the sun without understanding the biology or technology behind it,” says Dr. Yeargan. “That makes it difficult to determine exactly what is working and the clinical behavior that follows the interventions.” Dr. Yeargan uses validated outcomes instruments to evaluate every patient who undergoes the treatment and thinks that should be routine in any practice.

 

The FDA commented it would meet in April 2016 to discuss regenerative medicine regulatory measures but that meeting was postponed. The FDA is expected to announce the next meeting sometime this fall.

 

Some criteria may need to be established to determine who is qualified to deliver these treatments and who is not. “Literally any type of physician and many non-physician healthcare providers can practice regenerative medicine and that may not be in the best interest of patients,” Dr. Yeargan adds. “I think the companies who make the cell processing products must be responsible to who they are encouraging to perform the procedures and who they are selling the cell processors to.”

 

If the industry successfully advances the regenerative medicine field, Dr. Yeargan believes patients will continue to gain relief and payers could ultimately save money, as more patients avoid more expensive surgeries down the road. One can imagine a day when radiographic screening for early OA becomes routine if we are able to determine which patients are likely to benefit and when to intervene.